MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3AX1— 510(k) K040002

Substantially Equivalent

Microlife Intellectual Property Gmb

FDA 510(k) clearance K040002 for MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3AX1, Substantially Equivalent on 2004-03-22. Applicant: Microlife Intellectual Property Gmb.

Clearance details

Applicant: Microlife Intellectual Property Gmb
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2004-01-02
Decision date: 2004-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

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Adverse events under product code DXN

product code DXN

Death: 3
Injury: 169
Malfunction: 1,019
Other: 2
Total: 1,193

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.